Urinary Microbiome Changes Following Administration of 500 mg of NDS-446 in Women With Dry OAB at 12 Weeks

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to learn about how the use of 500 mg of dried cranberry powder extract (NDS-446) changes the bacteria that normal reside in the bladder of women who don't have urinary leakage problems but do have problems with urinary urgency and frequency.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Loyola University

Criteria

Inclusion Criteria:

• 18 years, female, ambulatory

• OAB symptoms > 6 months

• Voiding frequency > 8 times in 24 hrs and > 3 episodes of urgency (grade 3 or 4) without incontinence during 3-day diary at baseline

Exclusion Criteria:

• Self-reported urinary incontinence (> 3 episodes in the month prior)

• UTI > 3 in last 12 months

• A diagnosis of painful bladder syndrome or interstitial cystitis

• LUT surgery last 6 months

• Drug or non-drug treatment of OAB (previous 60 days) or current meds that affect detrusor activity

• On Warfarin

• Failure to complete 3-day diary

• Aspirin > 81 mg daily

• Gross hematuria

• Allergy or sensitivity to aspirin

• Subjects taking anti-platelet agents

• Inability to swallow capsules